Bristol-Myers Squibb Company (NYSE: BMY) is pleased to announce that today the National Institute of Health and Clinical Excellence (NICE) has decided to recommend YERVOY® (ipilimumab), which is approved in the European Union for the treatment of previously-treated metastatic (advanced) melanoma, within the Final Appraisal Determination (FAD). This important decision will enable eligible patients in England and Wales to routinely access treatment with YERVOY through the National Health Services (NHS).
"Today's decision is very welcome news and marks a major milestone in the treatment of advanced melanoma," said Dr. Paul Lorigan, Senior Lecturer in Medical Oncology, the Christie NHS Foundation Trust. "Ipilimumab's potential to provide a long-term survival benefit in some patients makes it an important treatment option and represents a genuine step change in the management of this disease."
Metastatic melanoma is the deadliest form of skin cancer with an average life expectancy of just six to nine months and a one-year mortality rate of 75%. YERVOY is the only approved treatment for metastatic melanoma to deliver a durable long-term survival benefit at two years for 24 percent of patients. In the pivotal study, which included more than 4.5 years of follow up, median overall survival was 10 months (95% CI: 8.0-13.8) for YERVOY and 6 months (95% CI: 5.5-8.7) for the gp100 control arm. Five-year follow up results from three Phase 2 exploratory studies were recently presented during the European Society of Medical Oncology congress (September 12 - October 2), adding to the growing body of long-term survival data for YERVOY in metastatic melanoma.
Overall, the types of adverse events (AEs) attributed to YERVOY are generally mechanism (immune)- based. YERVOY can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation. Adverse events associated with YERVOY are managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.
"Bristol-Myers Squibb is committed to leading advances in immuno-oncology, a field that is focused on harnessing the immune system to fight cancer and one that is increasingly recognized as a fourth pillar of the cancer-treatment platform," said Beatrice Cazala, executive vice president, commercial operations, Bristol-Myers Squibb. "YERVOY, the first-approved compound from our immuno-oncology pipeline, exemplifies how this type of medical innovation can address a significant unmet clinical need. We are pleased that our close collaboration with NICE on this appraisal over the past year has resulted in an outcome that is in the best interest of patients. Today's decision supports the UK government's statement that access to innovative medicines is a key driver for better patient outcomes."
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